This is multicenter placebo-controlled study evaluating the safety and efficacy of a 14-day treatment of AI at two dosage levels as compared to placebo, given twice daily, in CF patients with P. aeruginosa lung infection, delivered by the eFlow investigational nebulizer.

Eligibility

Ages Eligible for Study:

13 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Written informed consent prior to the performance of any study related procedures.

Administration of any antibiotic with antipseudomonal activity by any route within 56 days prior to Visit 1 (Screening).

Administration of any investigational drug or device within 28 days of Visit 1 (Screening) and within 6 half-lives of the investigational drug.

Oral corticosteroids in doses exceeding 10 mg per day or 20 mg every other day.

History of sputum culture or throat swab culture yielding B. cepacia in the previous two years.

Current daily continuous oxygen supplementation or requirement for more than 2 L/min at night.

Known local or systemic hypersensitivity to monobactam antibiotics.

Changes in antimicrobial, bronchodilator, anti-inflammatory or corticosteroid medications within 7 days prior to Visit 1 (Screening).

Changes in physiotherapy technique or schedule within 7 days prior to Visit 1 (Screening).

History of lung transplantation.

A chest radiograph at Visit 1 (Screening) or within the previous 90 days of Screening, with abnormalities indicating a significant acute finding (eg, lobar infiltrate and atelectasis, pneumothorax, or pleural effusion).

Positive pregnancy test. All women of childbearing potential will be tested.

Female of childbearing potential who is lactating or is not practicing acceptable method of birth control (eg, hormonal or barrier methods, or IUD).

Findings at Visit 1 (Screening) that, in the investigator's opinion, would compromise the safety of the patient or the quality of the study data.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055847